This invention relates to improved ibuprofen tablets/caplets characterized by a dissolution profile maintained stable on aging for up to two years. The tablets/caplets of the invention are formed by wet granulation of the ibuprofen to provide the dried base granulation for the compression mix.
In the past, most ibuprofen compressed tablets have been prepared from a wet granulation of a binder, such as starch, and ibuprofen which is dried, mixed with lubricants and disintegrating agents and compressed into tablets. Ibuprofen, however, is known to have unique dissolution characteristics when incorporated into compressed tablets. One attempt to provide a more stable dissolution profile to ibuprofen compressed tablets is described in U.S. Pat. No. 4,904,477 issued Feb. 27, 1990. That patent discloses a spray dried ibuprofen composition comprising finely divided ibuprofen in a gelatinized starch martrix of a generally spherical shape. The spray dried compositions comprise ibuprofen, as a disintegrant crospovidone, croscarmellose sodium and/or sodium starch glycolate, pregelatinized starch, colloidal silica and as a wetting agent polyvinylpyrrolidone and/or sodium lauryl sulfate. The patent further discloses that the spray dried ibuprofen can be incorporated into a compression mix together with starch, a disintegrant, such as croscarmellose sodium, and a wetting agent, such as sodium lauryl sulfate, to make compressed tablets. Because of the pertinence of U.S. Pat. No. 4,904,477, the disclosure of the patent is incorporated by reference herein in its entirely.